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FDA 510(k)

BioPlex 2200 Lyme Total

K-Number: K183446 · 2019-03-12

ApplicantBio-Rad Laboratories
Decision Date2019-03-12
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BioPlex 2200 Lyme Total is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories. It received FDA 510(k) clearance on 2019-03-12 under 510(k) number K183446. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioPlex 2200 Lyme Total?

BioPlex 2200 Lyme Total is a medical device that received FDA 510(k) clearance on 2019-03-12. The listed applicant is Bio-Rad Laboratories. The 510(k) number is K183446.

When did BioPlex 2200 Lyme Total receive FDA 510(k) clearance?

BioPlex 2200 Lyme Total received FDA 510(k) clearance on 2019-03-12, under 510(k) number K183446.

Who is the listed applicant for BioPlex 2200 Lyme Total?

The FDA 510(k) record lists Bio-Rad Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioPlex 2200 Lyme Total?

The FDA product code for BioPlex 2200 Lyme Total is LSR.

Other records listing Bio-Rad Laboratories as applicant

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Related Devices (Code: LSR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254295Sofia Lyme FIA; Sofia 2 Campylobacter FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho)K252627Lyme-ID IgG Test; Bio-ID800Inanovate, Inc.K242872iDart Lyme IgM ImmunoBlot KitId-Fish Technology, Inc.K233367iDart Lyme IgG ImmunoBlot KitId-Fish Technology, Inc.K230863ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control KitZeus ScientificK220016Viramed Borrela All-In-One ViraChip Test KitViramed Biotech AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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